The Effect of Vegetable Oil on Cognitive Functions of MCI Patients

NCT03727386 | Completed

• 1 other identifier: 1718/IRASREZ/1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the feasibility of applying an intervention using vegetable oils (coconut and sunflower oils) on individuals diagnosed with Mild Cognitive Impairment. Participants will be divided into two groups and will either receive 30 ml of coconut or sunflower oil to be consumed daily for six months.

Conditions

Metabolic Ketosis; Cognitive Impairments, Mild

Outcome Measures

Primary Outcomes (1)

• Vegetable oil usage

  the amount of oil used by individuals (ml) will be monitored

  6 months

Secondary Outcomes (10)

• Overall cognition

  Six months

• Quality of life of adults with Mild cognitive impairment measured by ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study Mild Cognitive Impairment- Activities of Daily Living)

  six months

• Dietary intake assessed by four day food records using Nutritics software

  six months

• Blood samples (beta hydroxyl butyrate):

  six months

• Executive measure

  six months

Study Arms (2)

Coconut oil

EXPERIMENTAL

A dietary intervention that relies on the administration of 30 ml of extra virgin coconut oil per day for six months will be utilized in this study. Coconut oil administered will replace the cooking/vegetable oil usually used by the participants. .

Other: Coconut oil

Sunflower oil

PLACEBO COMPARATOR

A dietary intervention that relies on the administration of 30 ml of sunflower oil per day for 6 months will be utilized in this study. The oil administered will replace the cooking/vegetable oil usually used by the participants.

Other: Sunflower oil

Interventions

Coconut oil OTHER

Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.

Also known as: extra virgin coconut oil

Coconut oil

Sunflower oil OTHER

Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.

Sunflower oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with confirmed MCI diagnosis
• Adults with Negative Apo E4 genotype

You may not qualify if:

• Adults diagnosed with Alzheimer's Disease (AD)
• Adults with positive Apo E4 genotype
• Adults with confirmed diabetes (Type I, Type II) diagnosis
• Adults with a history of hyper-cholesterolemia (high cholesterol levels) or Dyslipidaemia
• Adults who are unable to understand written or verbal English
• Adults diagnosed with Neurological disorders (Parkinson, stroke…)
• Adults with post traumatic brain injury (tumour, brain surgery, injury…)
• Patients with major physical impairments (blind, deaf) or those who are unable to use their dominant hand.
• Adults with coconut allergy.

Sponsors & Collaborators

• Bournemouth University: lead
• Dorset HealthCare University NHS Foundation Trust: collaborator

Study Sites (1)

Bournemouth University

Bournemouth, Dorset, BH1 3LH, United Kingdom

Location

MeSH Terms

Conditions

Ketosis; Cognitive Dysfunction

Interventions

Coconut Oil; Sunflower Oil

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Raysa EL Zein, MSc

  Student

  PRINCIPAL INVESTIGATOR

• Jane Murphy Professor, PhD

  Professor of Nutrition

  STUDY DIRECTOR

• Peter Thomas Professor, PhD

  Professor of Health Care Stats & Epidemiology

  STUDY DIRECTOR

• Shanti Shanker Doctor, PhD

  Lucturer of Psychology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a pilot study with an internal feasibility study that aims at evaluating the acceptance and adherence of participants to the intervention. Participants will be randomized into an intervention (coconut oil) and control group (sunflower oil) using an online randomisation software; Sealed envelope.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: November 1, 2018
• Study Start: November 19, 2019
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)